Tikosyn

Product NDC
69189-5820
11-digit product format
691895820
Labeler code
69189
Product ID
69189-5820_7c329776-808b-4c94-a77b-3c0d403917b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dofetilide
Dosage form
CAPSULE
Route
ORAL
Labeler
Avera McKennan Hospital
Application
NDA020931
Marketing category
NDA
Marketing start
2016-03-28
Marketing end
0000-00-00
Substance
DOFETILIDE
Active strength
1 mg/1
Pharmacologic classes
Antiarrhythmic [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc36b95-20ce-9079-16ec-f3cdb4dcf4fdProduct name920230112

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69189-5820-12020-01-31C16284748780-19d75b9d0-56a7-f424-e053-dadaa90a57ceTIKOSYN ® (dofetilide) Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69189-5820-1Tikosyn1 in 1 DOSE PACKCAPSULE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69189-5820TIKOSYN (DOFETILIDE) CAPSULE [AVERA MCKENNAN HOSPITAL]1Legacy NDC, 1 package rows20170411_b77b4388-36ec-4971-90a5-353879adb8b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310005dofetilide 500 MCG Oral CapsulePSNb77b4388-36ec-4971-90a5-353879adb8b51
285016Tikosyn 500 MCG Oral CapsulePSNb77b4388-36ec-4971-90a5-353879adb8b51
285016dofetilide 0.5 MG Oral Capsule [Tikosyn]SBDb77b4388-36ec-4971-90a5-353879adb8b51
310005dofetilide 0.5 MG Oral CapsuleSCDb77b4388-36ec-4971-90a5-353879adb8b51
310005dofetilide 500 MCG Oral CapsuleSYb77b4388-36ec-4971-90a5-353879adb8b51
285016Tikosyn 0.5 MG Oral CapsuleSYb77b4388-36ec-4971-90a5-353879adb8b51
285016Tikosyn 500 MCG Oral CapsuleSYb77b4388-36ec-4971-90a5-353879adb8b51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69189-5820-1691895820011 in 1 DOSE PACKHistorical